LUND, SE / ACCESS Newswire / February 5, 2026 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F)
OCTOBER - DECEMBER IN BRIEF
Net sales for the quarter amounted to KSEK 4 (KSEK 617)
The loss for the quarter amounted to KSEK -5,890 (KSEK -7,830)
Operating expenses for the quarter amounted to KSEK -6,943 (KSEK -10,223)
Earnings per share, before and after dilution, for the quarter amounted to SEK -0.01 (SEK -0. 02)
JANUARY - DECEMBER IN BRIEF
Net sales for the year amounted to KSEK 437 (KSEK 1,911)
The loss for the year amounted to KSEK -26,554 (KSEK -32,509)
Operating expenses for the year amounted to KSEK -31,766 (KSEK -40,626)
Earnings per share, before and after dilution, for the year amounted to SEK -0.07 (SEK -0. 11)
Cash and cash equivalents at the end of the year amounted to KSEK 29,672 (KSEK 32,470)
SIGNIFICANT EVENTS DURING THE QUARTER
The independent Data Monitoring Committee (DMC) recommended a dose escalation in the ongoing phase I/IIa Tumorad-01 study with the drug candidate 177Lu-SN201 in radiotherapy. In addition, significant visible tumor uptake of 177Lu-SN201 has been observed in SPECT images. The DMC considers this observation to be proof-of-concept for Tumorad in humans, indicating that 177Lu-SN201 may be a potential new treatment for cancer. This provides strong support for continued development, as well as an important basis for exploring opportunities in indications with potential for orphan drug status (ODD).
The company received approximately MSEK 24.4 after issuance costs in the rights issue, in which the subscription period expired on November 21. The net proceeds are intended to be used for the continued development of Tumorad, including dose escalation in the Phase I part of the study and preparations for the Phase IIa part of the study, including exploring opportunities for development paths in indications with potential for ODD.
CEO STATEMENT
As we sum up 2025, it is clear that the year has been both eventful and pivotal for Spago Nanomedical. During the final quarter, we took several important steps that together strengthen the clinical, regulatory, and financial foundation of the Tumorad program in preparation for its next phase of development.
One of the most significant milestones of the year came in October, when the independent Data Monitoring Committee (DMC) recommended a dose escalation in the ongoing Phase I/IIa study, Tumorad‑01, with our drug candidate ¹⁷⁷Lu‑SN201. The recommendation was based on a comprehensive review of available data, which continue to demonstrate a manageable and consistent safety profile, along with observations of clearly visible tumor uptake of ¹⁷⁷Lu‑SN201. The DMC concluded that the maximum tolerated dose (MTD) had not yet been reached and determined that the observation of tumor uptake could be regarded as Proof‑of‑Concept for Tumorad in humans. This represents a breakthrough for the program and provides important validation of our nanoparticle‑based platform for targeted delivery of radioisotopes to tumor tissue.
We are encouraged by the tumor uptake of ¹⁷⁷Lu‑SN201 observed in cancer patients. The most notable findings to date were seen in a patient with adenoid cystic carcinoma (ACC), a rare and aggressive cancer type for which no established treatment options are available in advanced stages of disease. These observations strengthen our conviction in Tumorad's potential across indications with high medical needs, while also sharpening our focus on regulatory interactions aimed at defining the path forward for the program, with a Phase II clinical study as the next step. This process includes assessing the potential to obtain orphan drug designation (ODD), initially within the ACC indication. Orphan designation offers several benefits, including regulatory guidance, fee reductions, and market exclusivity once a treatment has been approved. Advancing development within indications that qualify for ODD could facilitate both upcoming studies and future commercialization, while also increasing the project's attractiveness for potential partnerships.
The Phase I part of the Tumorad‑01 study continues to progress according to plan, with the overarching objective to document safety and establish the MTD or an appropriate therapeutic dose in preparation for the next clinical phase. Demonstrating MTD is considered a minimum requirement to meet regulatory expectations and attract potential licensing and development partners, and the ongoing dose escalation to 20 MBq/kg is therefore an important milestone from both a clinical and strategic perspective. The next DMC meeting is scheduled for March, when an initial analysis of data from this new dose level will be conducted. We look forward to the DMC's review and recommendation as we move closer to confirming a maximum tolerated dose and closure of the Tumorad Ph 1.
During the quarter, we also announced and completed an oversubscribed rights issue, raising approximately SEK 25 million before transaction costs. I am very pleased with the strong confidence shown by both existing and new shareholders in Spago Nanomedical. With strengthened financing, we can now continue the ongoing clinical development of Tumorad, and we see strong potential to create significant value for both patients and shareholders.
In parallel with the clinical work, we continuously evaluate various alternatives to secure long‑term financing, including for a planned Phase II study with ¹⁷⁷Lu‑SN201. Our focus is to maintain maximum flexibility ahead of the next stage of development while enhancing the program's attractiveness for strategic collaborations. I note with confidence that interest in radiopharmaceuticals remains strong, and the clinical data we are now generating further position Spago Nanomedical well within this rapidly growing and competitive field.
In summary, we close 2025 with strong clinical momentum and a clearer view of the strategic paths ahead. With the continued support of our shareholders, clinical partners, and employees, I look forward with great confidence to the next phase in the development of Tumorad and the company
Mats Hansen, CEO Spago Nanomedical AB
The interim report is available at the Company's website; https://spagonanomedical.se/investor-relations/#financial-reports
For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se
Spago Nanomedical AB is a Swedish company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise treatment and diagnosis of cancer and other debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker:SPAGO). For further information, see www.spagonanomedical.se.
FNCA Sweden AB is the Certified Adviser of the company.
Attachments
Spago Nanomedical year-end report January-December, 2025
SOURCE: Spago Nanomedical
View the original press release on ACCESS Newswire
